Ventiplus Disposable Manometer 0-60 Cm H2O; Ventiplus Disposable Manometer 0-20 Cm H2O; Ventiplus Disposable Manometer 0
by A Plus Medical 510(k)
Active
510(k) K102377
Overview
The Ventiplus Disposable Manometer is a mechanical pressure monitoring device that measures airway pressure using linear spring compression proportional to gas pressure. It is available in pressure ranges of 0-60 cm H2O and 0-20 cm H2O, with a disposable housing featuring graduated markings for easy reading. This device contains no electronic components, software, or requires an external energy source.
The Ventiplus Disposable Manometer is designed for single patient use and is intended for monitoring airway pressure in clinical settings. It is regulated under FDA 510(k) clearance with product code CAP and is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) under regulation 868.2600. The device is supplied in disposable form and requires appropriate storage conditions as specified by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102377 | Date18 Nov 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAP
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2600
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent